Regulating Together in Tuberous Sclerosis Complex

Launched by UNIVERSITY OF ROCHESTER · Oct 23, 2023

Keywords

ClinConnect Summary

The clinical trial titled "Regulating Together in Tuberous Sclerosis Complex" is exploring a program called Regulating Together (RT). This program is designed to help children and teenagers with Tuberous Sclerosis Complex (TSC) and related behavioral challenges, such as temper tantrums, aggressive outbursts, and impulsive actions. The goal is to provide a remote treatment option that doesn't involve medication, making it more accessible for families.

To participate, children aged 8 to 17 who have been diagnosed with TSC and show signs of behavioral difficulties may be eligible. It's important that they, along with their caregivers, can communicate in English and have access to a device with video capabilities and a stable internet connection. The study is currently looking for participants, and if families face challenges with technology access, help will be provided to connect them with resources. Throughout the trial, participants will attend treatment sessions designed to improve emotional regulation skills. However, those on certain medications or with specific disruptive behaviors may not qualify. This trial aims to make a positive impact on the lives of children with TSC and their families by providing valuable support and tools for managing emotions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Children ages 8-17 years inclusive with a documented clinical and/or genetic diagnosis of TSC and exhibiting symptoms of behavioral dysregulation (identified on the TAND Checklist having temper tantrums, aggressive outbursts, self-injury, and/or impulsivity) are eligible for inclusion.
• Additional inclusion/eligibility criteria include:
• • Participants and their caregivers have access to a computer, phone, or tablet with video capability and stable internet connection. If lack of a device or internet service is the sole barrier to eligibility/participation, interested individuals will be connected to a TSC Clinic social worker to link them to existing government and charity programs specifically addressing this disparity in underserved communities and households in need (e.g., the Affordable Connectivity Program).
• • Participants must also be willing to participate in treatment sessions and have minimal levels of functional verbal communication (child and their caregiver must be fluent in English
• • Child must have a minimum IQ\>65 on the WASI-II at the screening/baseline visit).
• Exclusion Criteria:
• • Participants be on a stable medication regimen at least 4 weeks prior to enrollment
• • Do not have a plan to start a new psychosocial intervention (e.g., individual psychotherapy, family psychotherapy, group psychotherapy or social skills training) or behavior medication within 30 days prior to enrollment or at any point during the study. ----Participants with significant disruptive, aggressive, self-injurious or sexually inappropriate behaviors deemed potentially dangerous or overly disruptive to the group dynamic/session, having significant co-occurring neuropsychiatric illness warranting other treatment approaches as determined by study clinician (e.g., substance use disorders, psychotic disorders, schizophrenia), or having significant sensory impairment that would limit participation in intervention curriculum/materials (e.g., blindness or uncorrected hearing loss) also will be excluded.